Agilent Technologies M3860A User manual

User’s Guide
Agilent M3860A, M3861A Heartstream FR2
Semi-Automatic External Defibrillator (AED)

The HEARTSTREAM
FR2 AED
Clockwise from top right.
Battery. Disposable
battery pack used to
power the HEARTSTREAM
FR2. (Check local
regulations for disposal
and recycling
requirements.)
On/Off button. turns
on the FR2 and starts
voice and screen prompts.
Second press turns off the
FR2.
Status Indicator.
This shows you the
readiness status of the
HEARTSTREAM FR2.
Display screen.
Displays text prompts and
incident data. The
HEARTSTREAM FR2
M3860A screen also displays the
patient’s ECG.
Option buttons. Adjust the
contrast of the screen display and
control special functions.
Beeper port. Broadcasts alert
beeps when required. It is located
under the right edge of the FR2.
Infrared (IR) communications
port. A special lens, or “eye,” used to
transfer data directly to or from
another device.
Data card port. Receptacle for
data card tray.
Data card (optional). Used to
store and review information about the
incident, including ECG and optional
voice recording.
Data card tray. Special sleeve
that holds the data card and fits into
the data card port to help seal the FR2
against fluids. The tray should be kept
installed in the FR2 even if no data
card is used.
Microphone. Used optionally to
record surrounding audio during an
incident. It is located under the right
edge of the FR2.
Shock button. Controls shock
delivery. The button flashes when the
HEARTSTREAM FR2 is ready to deliver
a shock.
Speaker. Amplifies voice
prompts during use of the FR2.
Pads placement diagram.
Illustrates correct placement of pads.
Diagrams are also shown on the back
of the defibrillation pads.
Defibrillator pads connector
port. Receptacle for connector of the
defibrillation pads cable. An adjacent
LED light flashes to show socket
location and is covered when
connector is inserted.
Defibrillator pads assembly.
Self-adhesive pads with attached cable
and connector.
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HEARTSTREAM FR2 AED
QUICK REFERENCE GUIDE

Notice
About This Edition
The information in this guide
applies to the Agilent Technologies
models M3860A and M3861A
HEARTSTREAM FR2 semi-automatic
external defibrillator. This
information is subject to change
without notice.
Agilent Technologies shall not be
liable for errors contained herein or
for incidental or consequential
damages in connection with the
furnishing, performance, or use of
this material.
Edition History
Edition 4
Publication date: March 2000
Publication number: M3860-91900
Assembly number: 011120-0004
Printed in the U.S.A.
Copyright
Copyright © 2000
Agilent Technologies
Heartstream Operation
2401 Fourth Avenue, Suite 500
Seattle, WA 98121, USA
[phone]
This document may not be
photocopied, reproduced, or
translated to another language
without prior written consent of
Agilent Technologies.
Authorized
EU Representative:
Agilent Technologies GmbH
Health Care Solutions Group
Herrenberger Strasse 110-140
71034 Boeblingen, Germany
[phone]
CAUTION
FEDERAL LAW (USA)
RESTRICTS THIS DEVICE TO
SALE BY OR ON THE ORDER
OF A PHYSICIAN.
The HEARTSTREAM FR2 is
designed to be used only with
Agilent Technologies-approved
accessories. The HEARTSTREAM
FR2 will perform improperly if
non-approved accessories are used.
Agilent Technologies, Inc.
United States
Agilent Technologies, Inc.
Healthcare Solutions Group
Heartstream Operation
2401 Fourth Avenue, Suite 500
Seattle, Washington 98121-1436
[phone]
1-800-263-3342
Canada:
Agilent Technologies, Inc.
5150 Spectrum Way
Mississauga, Ontario L4W 5G1
[phone]
1-800-291-6743
Europe:
Agilent Technologies, Inc.
Healthcare Solutions Group
Herrenberger Strasse 110-140
71034 Boeblingen, Germany
([phone]
Medical Distribution:
Europe/Middle East/Africa
Agilent Technologies, Inc.
1217 Meyrin 1
Geneva, Switzerland
([phone]
Latin America:
Agilent Technologies, Inc.
5200 Blue Lagoon Drive
Miami, FL 33126 USA
[phone]
Asia Pacific Headquarters:
Agilent Technologies, Inc.
24F Cityplaza One
1111 King’s Road
Taikoo Shing, Hong Kong
([phone]
www.agilent.com/healthcare

i
Contents
1 Introduction to the HEARTSTREAM FR2
What is the HEARTSTREAM FR2? ........................................................................................................1-1
When Is the HEARTSTREAM FR2 Used? .............................................................................................1-2
How Does the HEARTSTREAM FR2 Work? .........................................................................................1-2
How Is the HEARTSTREAM FR2 Supplied? .........................................................................................1-3
2 Preparing Your HEARTSTREAM FR2 for Use
Overview .............................................................................................................................................2-1
Installing the Battery ...........................................................................................................................2-1
Setting the Clock .................................................................................................................................2-3
Running the Battery Insertion Selftest ................................................................................................2-4
Placing and Securing the HEARTSTREAM FR2 ....................................................................................2-5
3 Using Your HEARTSTREAM FR2
Overview .............................................................................................................................................3-1
Step 1: Preparation ..............................................................................................................................3-2
Step 2: ECG Analysis and Monitoring ................................................................................................3-3
Step 3: Shock Delivery ........................................................................................................................3-4
4 Troubleshooting, Testing, and Maintaining Your HEARTSTREAM FR2
Overview .............................................................................................................................................4-1
Troubleshooting Guide ........................................................................................................................4-1
Status Indicator Summary .............................................................................................................4-2
Status Indicator Details .................................................................................................................4-3
Battery ...........................................................................................................................................4-5
Defibrillation Pads ........................................................................................................................4-6
Rhythm Analysis and Defibrillation .............................................................................................4-7
Testing .................................................................................................................................................4-8
Battery Insertion Selftest ..............................................................................................................4-8
Periodic Selftests ........................................................................................................................4-12
Device History ............................................................................................................................4-12
Battery History ............................................................................................................................4-13
Maintenance ......................................................................................................................................4-13
Maintenance Schedule ................................................................................................................4-13
Operator’s Checklist ...................................................................................................................4-15
Cleaning the HEARTSTREAM FR2 ...............................................................................................4-17

ii
Contents
5 Clinical and Safety Considerations
Clinical Considerations .......................................................................................................................5-1
Indications .....................................................................................................................................5-1
Contraindications ..........................................................................................................................5-1
Safety Considerations ..........................................................................................................................5-2
General Dangers, Warnings, and Cautions ...................................................................................5-2
Defibrillation Warnings and Cautions ..........................................................................................5-4
Monitoring Cautions .....................................................................................................................5-5
Maintenance Cautions ..................................................................................................................5-6
6 Setup and Advanced Mode Features
Setup Overview ...................................................................................................................................6-1
Non-Protocol Parameters ..............................................................................................................6-1
Automatic Protocol Parameters ....................................................................................................6-2
Manual Override Parameters ........................................................................................................6-4
Using Setup Features ...........................................................................................................................6-6
Reviewing Current Setup ..............................................................................................................6-6
Revising Setup ..............................................................................................................................6-7
Receiving Setup ............................................................................................................................6-8
Reading Setup ...............................................................................................................................6-8
Sending and Receiving Clock Settings ...............................................................................................6-9
Using Advanced Mode Features .......................................................................................................6-10
Using the Manual Analyze Feature ............................................................................................6-11
Using the Manual Charge Feature (M3860A only) ....................................................................6-12
7 Data Management and Review
Overview .............................................................................................................................................7-1
Recording Incident Data ......................................................................................................................7-1
Recording Data in Internal Memory .............................................................................................7-1
Recording Data on a Data Card ....................................................................................................7-1
Reviewing Incident Data .....................................................................................................................7-3
Reviewing Data from Internal Memory .......................................................................................7-3
Reviewing Data from a Data Card ................................................................................................7-4

iii
Contents
A Accessories for the HEARTSTREAM FR2
HEARTSTREAM Accessories ................................................................................................................A-1
Suggested Additional Items ...............................................................................................................A-1
B Technical Specifications
HEARTSTREAM FR2 AED Specifications ........................................................................................... B-1
Physical ........................................................................................................................................ B-1
Environmental .............................................................................................................................. B-1
Defibrillator ................................................................................................................................. B-2
ECG Analysis System .................................................................................................................. B-4
ECG Analysis Performance ......................................................................................................... B-4
Display ......................................................................................................................................... B-5
Controls and Indicators ................................................................................................................ B-6
Accessories Specifications ................................................................................................................. B-6
M3863A Battery Pack Specifications .......................................................................................... B-6
HEARTSTREAM Defibrillation Pads Specifications ...................................................................... B-7
(Optional) M3854A Data Card Specifications ............................................................................ B-7
C Differences between the FORERUNNER and the HEARTSTREAM FR2 AEDs
D Glossary of Symbols and Controls
E Glossary of Terms
Index

iv
Notes

M3860A and M3861A HEARTSTREAM FR2 Defibrillator 1-1
1 Introduction to the HEARTSTREAM FR2
What is the HEARTSTREAM FR2?
The HEARTSTREAM FR2 defibrillator (“FR2”) is a semi-automatic external
defibrillator (AED). It is compact, lightweight, portable, and battery powered.
It is designed for simple and reliable operation by a trained responder.
The HEARTSTREAM FR2 has a Status Indicator that is always active, so you
can tell at a glance if it is ready for use. The front panel of the FR2 has an
On/Off button at the top and a Shock button at the bottom. A display screen in
the center of the panel provides text prompts and incident information. Voice
prompts are provided through a speaker located at the base of the FR2. (See
the diagram on the inside front cover for details.)
The HEARTSTREAM FR2 is available in two models, the M3860A and the
M3861A. They share a set of basic features. In addition, the M3860A
provides optional screen display of the patient’s electrocardiogram (ECG) and
can be programmed to permit the advanced mode’s manual charge feature.
NOTE: The FR2 comes with a factory default setup that can be modified.
(See Chapter 6, Setup and Advanced Mode Features, for a description of
setup defaults and options.)

When Is the HEARTSTREAM FR2 Used?
1-2 Introduction to the HEARTSTREAM FR2
When Is the HEARTSTREAM FR2 Used?
The HEARTSTREAM FR2 is used with disposable HEARTSTREAM defibrillation
pads applied to a person who is experiencing the symptoms of sudden cardiac
arrest (SCA): lack of consciousness, lack of breathing, and lack of detectable
pulse. Defibrillation should not be performed on anyone who is conscious,
breathing, or has a detectable pulse.
The HEARTSTREAM FR2 is intended for use by emergency care personnel who
have been specifically trained in the operation of the HEARTSTREAM FR2 or
who are qualified by training in Basic Life Support (BLS), in Advanced Life
Support (ALS), or in other physician-authorized emergency medical response.
The HEARTSTREAM FR2 is not intended for administration of energy at
pediatric energy settings. In accordance with the recommendations of the
American Heart Association,*the HEARTSTREAM FR2 should not be used to
treat infant cardiac arrest, but standard operating procedures should be
followed in treating children over eight years of age.
How Does the HEARTSTREAM FR2 Work?
The HEARTSTREAM FR2 is designed to provide external defibrillation therapy
to someone in cardiac arrest. Defibrillation therapy is the best available way
to treat a variety of potentially fatal heart arrhythmias.
The FR2 is extremely easy to use. When connected to defibrillation pads that
are properly applied to the patient’s bare chest, the HEARTSTREAM FR2:
1. prompts you to take specific actions,
2. automatically analyzes the patient's heart rhythm and advises you whether
or not the rhythm is shockable, and
3. arms the Shock button, if appropriate, and instructs you to press it to
deliver a biphasic electric pulse designed to defibrillate the heart.
Detailed instructions for use are provided in Chapter 3.
* Textbook of Advanced Cardiac Life Support. Dallas: AHA, 1997-99.

How Is the HEARTSTREAM FR2 Supplied?
M3860A and M3861A HEARTSTREAM FR2 Defibrillator 1-3
1
How Is the HEARTSTREAM FR2 Supplied?
The HEARTSTREAM FR2 is supplied with a battery pack, defibrillation pads
with integrated cable and connector, and a data card tray. Other accessories
are available. See Appendix A for a list of accessories and other
recommended supplies.

How Is the HEARTSTREAM FR2 Supplied?
1-4 Introduction to the HEARTSTREAM FR2
Notes

M3860A and M3861A HEARTSTREAM FR2 Defibrillator 2-1
2 Preparing Your HEARTSTREAM FR2 for Use
Overview
There are a few basic steps to preparing your HEARTSTREAM FR2 for use:
Install a battery.
Set the clock in the FR2 (optional).
Run the battery insertion selftest.
Place the FR2 with recommended accessories in a convenient location.
The instructions presented here briefly describe the normal sequence of
preparation. It assumes that you are using a fresh battery, that the selftest
passes, and that the factory default settings will not be changed. Exceptions to
this sequence are provided elsewhere in this User’s Guide.
Installing the Battery
The HEARTSTREAM FR2 is shipped with a M3863A battery pack. The battery
is enclosed in a gray plastic case. There is a yellow latch at one end that holds
the battery pack in place when it is correctly installed in the FR2. To install
the battery:
1. Hold the battery pack by the latch end and slide it into the battery
compartment at the top of the HEARTSTREAM FR2.
2. Slide the battery all the way into the opening, until the latch clicks into
place. The latch will click into place only when the battery is inserted
correctly.
CAUTION: Follow all instructions supplied with the HEARTSTREAM M3863A battery pack Install the
battery before the expiration date shown on the battery

Installing the Battery
2-2 Preparing Your HEARTSTREAM FR2 for Use
When the battery is installed, the HEARTSTREAM FR2 automatically turns on.
The Status Indicator displays a flashing black hourglass. The Shock button
light flashes once, and the indicator light for the defibrillation pads connector
port comes on.
The display screen brings up the main menu. From this menu, you can start
the FR2 battery insertion selftest, review information from the last time the
FR2 was used, or go to the next screen for other options. Information about
the optional data card and the battery status is also provided. (See Chapter 7,
Data Management and Review, for details about reviewing an incident and
using a data card.)
NOTE: This screen will not be displayed if the defibrillation pads are connected to
the FR2 when the battery is inserted, and you will not be able to access the menu
items. In addition, the battery insertion selftest and periodic automatic selftests cannot
run while the defibrillation pads are connected. Be sure to unplug the pads connector
from the FR2 after each use. Do not store the FR2 with the pads connected.
NOTE: To move around the menus displayed, use the Option buttons as follows:
• Press the LOWER Option button to move the highlight bar from one item to
another on the menu.
• Press the UPPER Option button to select the highlighted item or to scroll through
the settings for that item.
The menu displayed if you select NEXT lets you review the history of the
FR2, review the history of the battery being used, access setup data, set the
clock, or return to the first menu. (See Chapter 4, Troubleshooting, Testing,
and Maintaining Your HEARTSTREAM FR2, for details about the review
options and Chapter 6, Setup and Advanced Mode Features, for information
on the setup option.)
NOTE: If you make no selection for 10 seconds, the selftest will automatically run.
If you want to select something different from either of these menus, you must do so
before the selftest begins, or remove and reinstall the battery to bring up the main
menu. You can press the On/Off button at any time to turn off the FR2 and return it to
standby (ready for use) mode.
RUN SELFTEST
REVIEW INCIDENT
NO DATA CARD
GOOD BATTERY
NEXT
IN EMERGENCY
PRESS OFF TO QUIT
DEVICE HISTORY
BATTERY HISTORY
SETUP
CLOCK
RETURN
IN EMERGENCY
PRESS OFF TO QUIT

Setting the Clock
M3860A and M3861A HEARTSTREAM FR2 Defibrillator 2-3
2
Setting the Clock
It is recommended that the first time you prepare your HEARTSTREAM FR2 for
use, you check the FR2’s internal clock to be sure it is set to the correct date
and local time. You can reset it if necessary.
To see the clock settings, select NEXT from the first menu, within 10 seconds
of installing the battery, and then select CLOCK. To do this:
1. Press the lower Option button to move the highlight bar to NEXT.
2. Press the upper Option button to bring up the NEXT screen.
3. Press the lower Option button to move the highlight bar to CLOCK.
4. Press the upper Option button to bring up the CLOCK screen.
The CLOCK screen displays the time and date currently set in the internal
clock of the HEARTSTREAM FR2.
NOTE: The date is displayed as day (DD), month (MM), and year (YY), as shown on
the screen. The time is displayed using the 24-hour international clock.
If no changes to the clock settings are needed, select RETURN and go back to
the first menu. If the time and date are not correct, there are two ways to set
them:
Receive the clock settings from another HEARTSTREAM FR2 or from a
computer using CODERUNNER® software, using the RECEIVE TIME
option. This may be used to synchronize the clocks of several FR2s. You
can also send the clock settings from one FR2 to another one, using the
SEND TIME option. See Chapter 6, Setup and Advanced Mode Features,
for instructions.
Manually set the date and the time.
To manually set the clock:
1. Use the lower Option button to move the highlight bar to the part of the
clock setting you want to change.
2. Use the upper Option button to scroll through the settings until you reach
the one you want. If you go past it, keep scrolling until it comes up again.
RUN SELFTEST
REVIEW INCIDENT
NO DATA CARD
GOOD BATTERY
NEXT
IN EMERGENCY
PRESS OFF TO QUIT
DEVICE HISTORY
BATTERY HISTORY
SETUP
CLOCK
RETURN
IN EMERGENCY
PRESS OFF TO QUIT
CLOCK
RETURN
RECEIVE TIME
SEND TIME
07 / 09 / 00
DD / MM / YY
14 : 28
CLOCK
RETURN
RECEIVE TIME
SEND TIME
07 / 09 / 00
DD / MM / YY
14 : 28

Running the Battery Insertion Selftest
2-4 Preparing Your HEARTSTREAM FR2 for Use
3. Use the lower Option button to select the next part you want to change,
and repeat the process, until all parts of the time and date have been set.
4. When you have made all the changes, move the highlight bar to RETURN
and press the upper Option button to go back to the main menu screen.
NOTE: New clock settings are used by the FR2 as soon as you set them. The clock
time display is updated each minute this screen is displayed. The clock seconds,
although not displayed, are set to 00 when you move the highlight bar out of the time
settings.
NOTE: If the battery is removed from the FR2 for more than two hours, the clock
settings will be lost and must be reset.
Running the Battery Insertion Selftest
Except in an emergency, it is recommended that you run this selftest every
time you change the battery.
The selftest has two parts. The first part tests the FR2 circuitry and memory.
The second part is interactive and requires you to respond to prompts in order
to make sure the display, buttons, lights, speaker, and beeper of the
HEARTSTREAM FR2 are working properly. (See Chapter 4, Troubleshooting,
Testing, and Maintaining Your HEARTSTREAM FR2, for details about this
selftest.)
To run the selftest:
1. Make sure the FR2 has not been in use for at least 5 minutes, and that the
defibrillation pads are not connected to the device.
2. Insert the battery into the battery port. The first screen displayed has RUN
SELFTEST highlighted.
3. Press the upper Option button to activate the test.
4. OR, make no selection for 10 seconds, and the selftest will start
automatically.
When the first part of the selftest is successfully completed, the screen
displays a message that the test has passed, and then automatically starts the
RUN SELFTEST
REVIEW INCIDENT
NO DATA CARD
GOOD BATTERY
NEXT
IN EMERGENCY
PRESS OFF TO QUIT

Placing and Securing the HEARTSTREAM FR2
M3860A and M3861A HEARTSTREAM FR2 Defibrillator 2-5
2
interactive part of the selftest. (See Chapter 4, Troubleshooting, Testing, and
Maintaining Your HEARTSTREAM FR2, for details about the interactive part of
the test.)
When the selftest is complete, the HEARTSTREAM FR2 automatically turns off
and returns to standby mode. The Status Indicator shows a flashing black
hourglass. In the standby mode, the FR2 is ready for use at any time, simply
by pressing the On/Off button to turn it on.
Placing and Securing the HEARTSTREAM FR2
Place the HEARTSTREAM FR2 in an accessible area with the Status Indicator
easily visible. Useful accessories for placing and securing the FR2 include a
carrying case, which is suitable for use with a wall mount bracket. (See
Appendix A for a list of accessories.)
With the battery installed and the FR2 stored in appropriate environmental
conditions, the HEARTSTREAM FR2 performs detailed periodic selftests, to
make sure that it remains ready for use. (See Appendix B for the
environmental storage specifications.)
While the FR2 is in the standby mode, the Status Indicator shows the flashing
black hourglass unless the periodic selftests detect a problem. If a problem is
detected, the Status Indicator will show a flashing red Xor a solid red Xand
the FR2 will “chirp” to alert you to the need for troubleshooting. (See Chapter
4, Troubleshooting, Testing, and Maintaining Your HEARTSTREAM FR2, for
instructions.)
SELFTEST PASSED
REV: 01EM30 0201
NO DATA CARD
SN 000000001
IN EMERGENCY
PRESS OFF TO QUIT

Placing and Securing the HEARTSTREAM FR2
2-6 Preparing Your HEARTSTREAM FR2 for Use
Notes

M3860A and M3861A HEARTSTREAM FR2 Defibrillator 3-1
3UsingYourHEARTSTREAM FR2
Overview
This chapter describes how to use the HEARTSTREAM FR2 in an emergency
incident. Some general things to remember are:
Try to relax and stay calm. The HEARTSTREAM FR2 automatically
provides appropriate voice and display prompts to guide you.
The defibrillation pads must have good contact with the patient’s
skin. The pads have a layer of sticky, conductive gel beneath the
protective backing. To work effectively, the gel must not be dried out.
It may be necessary to dry the patient’s chest or to clip or shave
excessive chest hair to provide good contact between the
defibrillation pads and the patient’s skin.
The following pages provide step-by-step instructions for normal use of the
HEARTSTREAM FR2 in an emergency. (See Chapter 4, Troubleshooting,
Testing, and Maintaining Your HEARTSTREAM FR2, for troubleshooting tips.)
Be sure to read the Warnings and Cautions on the last page of this chapter.
NOTE: These directions apply to both the model M3860A and the model M3861A
HEARTSTREAM FR2, except where otherwise noted.

Step 1: Preparation
3-2 Using Your HEARTSTREAM FR2
Step 1: Preparation
Press the On/Off button to turn on the HEARTSTREAM FR2. Follow
the instructions provided by the FR2 voice and screen prompts in
the order indicated.
Remove clothing from the patient's chest. Wipe moisture from the patient's
chest and clip or shave excessive chest hair, if necessary.
Open the defibrillation pads package. Check to see that the pads and attached
cable and connector are undamaged. Pull off the protective backing from the
defibrillation pads and check that the gel has not dried out. If the pads are
damaged or the gel has dried out, use a new set of pads.
Place each pad on the patient. The pads must be placed with the sticky side on
the patient’s skin. IMPORTANT: Refer to the drawing on the back of each pad
for correct positioning. One pad goes just below the patient's right collarbone,
and the other one goes over the patient’s ribs in line with the armpit and below
the left breast.
Connect the pads to the HEARTSTREAM FR2. Insert the defibrillation pads
connector firmly in the connector socket. A flashing light shows you where
the socket is located, at the top left of the HEARTSTREAM FR2.
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